WHO Pharmaceuticals Newsletter 1998, No. 11&12
(1998; 10 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAcetylsalicylic acid and paracetamol: stricter controls: UK
View the documentAlcohol warning: revised labelling of all OTC pain relievers & fever reducers: USA
View the documentCamphor and/or menthol: warning concerning fire hazard: USA
View the documentCholestin: determined to be an unapproved drug: USA
View the documentCorticosteroids (inhaled and intranasal formulations): new labelling required for use in children: USA
View the documentEphedrine and atropine: not accepted in final monographs for OTC internal analgesic or menstrual use: USA
View the documentEritrityl tetranitrate: withdrawal of approval: lack of efficacy: USA
View the documentL-desoxyephedrine (levmetamfetamine): added to monograph for OTC nasal decongestant drug products: USA
View the documentMagnesium sulfate: revised labelling: UK
View the documentNucleoside analogues: revised product information: hepatic steatosis and lactic acidosis: Portugal
View the documentPovidone-iodine: warning concerning overdosage: Austria
View the documentSoy protein and coronary heart disease: new health claim proposed: USA
View the documentTick-borne encephalitis virus vaccine: paediatric formulation withdrawn: adverse reactions: Germany
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsMedication errors
Open this folder and view contentsVeterinary medicine
 

Corticosteroids (inhaled and intranasal formulations): new labelling required for use in children: USA

United States of America. The Food and Drug Administration is requiring new paediatric information on the labelling of all orally inhaled and intranasal corticosteroids. The new labelling will alert health care providers that using these drugs in children may reduce their rate of growth. The labelling will also recommend using the lowest effective dose of these drugs and routinely monitoring patients’ growth rates. Inhaled corticosteroids are used to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first consulting their health care providers about the benefits of these drugs compared to their risks. Manufacturers will continue to monitor these drugs to ascertain long-term effects.

Reference: FDA Talk Paper T98-79 dated 9 November 1998. [http://www.fda.gov/bbs/topics]

to previous section to next section
 

Last updated: May 3, 2013